RecruitingPhase 1Phase 2NCT05827796

IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer

A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer


Sponsor

InxMed (Shanghai) Co., Ltd.

Enrollment

70 participants

Start Date

Dec 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicenter, open-label, single-arm, phase Ib/II clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new targeted cancer drug called IN10018 (a FAK inhibitor) in combination with standard chemotherapy, with or without an additional immunotherapy drug (KN046), for people with advanced pancreatic cancer that has not yet been treated with chemotherapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with advanced, locally advanced, or metastatic pancreatic ductal adenocarcinoma - You have not received any prior chemotherapy for your pancreatic cancer - You have at least one measurable tumor on scans - Your ECOG performance status is 0 or 1 (you are fairly active and independent) - Your organ function (bone marrow, liver, kidneys) meets requirements - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have had major surgery or a serious injury in the past 28 days - You have a known BRCA1 or BRCA2 gene mutation - You have had previous immunotherapy (PD-1/PD-L1/CTLA-4 targeted treatment) - You have received radical radiation in the past 3 months - You are currently taking strong medications that interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIN10018

IN10018 orally once daily at approximately the same time each day, to ensure a dosing interval of approximately 24 hours.

DRUGAlbumin-Bound Paclitaxel

Albumin-bound paclitaxel will be administered as per the schedule specified in the respective arm.

DRUGGemcitabine

Gemcitabine will be administered as per the schedule specified in the respective arm.

DRUGKN046

KN046 5 mg/kg on Day 1 of each 21-Day Cycle.


Locations(1)

Renji Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT05827796


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